25-羟基维生素D检测试剂盒的性能验证

Performance verification of detection reagents for 25-hydroxy vitamin D

目的采用酶联免疫吸附试验(ELISA)法检测25-羟基维生素D水平,对试剂盒性能进行系统评价。方法参照美国临床和实验室标准化协会(NCCLS)的文件标准,从精密度、准确度、线性范围、检出限、干扰性试验5个方面对试剂盒检测25-羟基维生素D的能力进行性能验证。结果试剂盒测定25-羟基维生素D的批内与批间不精密度均≤5%;准确度的评估通过定值质控品相对偏差≤8%;拟合曲线(三次多项式)分析,r2≥0.99,线性关系较好;25-羟基维生素D的最低检出限为5 nmol/L;干扰物血红蛋白、胆红素、油脂浓度未达到极高界限,25-羟基维生素D的检测结果在可以接受的范围之内。结论 25-羟基维生素D测定试剂盒的精密度、准确度、线性范围、检出限、干扰性均符合临床检测维生素D的要求。

Objective To detect the 25- hydroxy vitamin D level with enzyme linked immunosorbent assay（ ELISA） and systematically value the performance of reagents. Methods Referring to NCCLS document,the precision,accuracy,linear range,the minimum detection limit and interference test of 25- hydroxy vitamin D detection reagents were verified. Results The precision of intra- and inter batch were ≤5%; the bias of constant value quality control was ≤8%; the analysis of fitting curve was conducted,r2≥0. 99,and the linear range was good; the minimum detection limit was 5 nmol/L; the concentration of interference material included hemoglobin,bilirubin and oil didn＇t reach to the limit,and the detection results of 25- hydroxy vitamin D was within the acceptable limits. Conclusion The precision,accuracy,linear range,detection limit,interference of25- hydroxy vitamin D detection reagents can meet the needs of clinical diagnosis.